MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-02-04 for IMPERV, ISOLATION GOWN W/THUMBHOOKS 30/C 42110PG manufactured by Cardinal Health.
[983236]
Pt care technician developed rash/itching on forearms and neckline after wearing the gown. She went the employee health where she refused benadryl, but did receive a topical cream which did not provide relief from the itching. She saw her personal physician who treated her with medication that did relieve her symptoms, and she is now symptoms free.
Patient Sequence No: 1, Text Type: D, B5
[8161247]
The customer was unable to provide the lot number and the sample, therefore, the actual root cause could not be determined. However, testing was done on ten people who wore the gown to identify if any irritation occurred. No abnormalities were found. In addition, reserved samples were sent for irritation and allergy testing. No irritation/allergy was found. We will continue to monitor for complaints of this nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2009-00020 |
| MDR Report Key | 1305609 |
| Report Source | 05,07 |
| Date Received | 2009-02-04 |
| Date of Report | 2009-02-04 |
| Date of Event | 2009-01-07 |
| Date Mfgr Received | 2009-01-08 |
| Date Added to Maude | 2010-07-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN RD, BLDG KB |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475786412 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPERV, ISOLATION GOWN W/THUMBHOOKS 30/C |
| Generic Name | SURGICAL ISOLATION GOWN |
| Product Code | OEA |
| Date Received | 2009-02-04 |
| Catalog Number | 42110PG |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-02-04 |